Audrey Jones was taking part in a clinical trial of the new diabetes drug Rezulin when she became critically ill.
"The doctor informed me that she was going to be put on the list for a liver transplant and she had to go into intensive care," says Audrey's husband Elmer Jones.
Audrey is one of 33 people to died from liver failure while taking Rezulin. It is a statistic that has prompted calls to take the drug off the market. The drug's manufacturer acknowledges there are problems.
"The reality is that all medications have some risk. In this situation, we're fortunate with Rezulin to have substantial benefit as well," says Dr. Robert Zerbe of Park-Davis.
The FDA was aware that Rezulin could cause liver damage in about 2% of patients when it approved the drug in January of 1997.
But only after 35 reports of liver injury and one death, did the FDA issue new recommendations for liver testing in patients on Rezulin.
Just a month later, those guidelines were tightened further and this summer, the drug's manufacturer sent doctors even stricter recommendations.
Rezulin helps patients with type II diabetes which develops in adulthood. In order to maintain lower levels of blood sugar in some patients, Rezulin reduces the need for insulin.
Doctor Zachary Bloomgarden of Mount Sinai Hospital, who has received funds from the drug's maker, says "As long as Rezulin treatment is followed carefully by the doctor and the patient, its benefits clearly outweigh its risks."
In the U.S. Rezulin will stay on the market for now, though the FDA continues to gather more information about its side effects. And, while the drug was withdrawn from sale in Great Britain because of liver damage, a new application has been submitted for its approval there.
Reported By John Roberts